Last updated 26 days ago
Study of Ianalumab Versus Placebo in Addition to First-line Corticosteroids in Primary Immune Thrombocytopenia (ITP)
225 patients around the world
Available in Spain, Mexico, United States
This is a multi-center, randomized, double-blind Phase 3 study to assess the efficacy and
safety of two different doses of ianalumab compared to placebo in adults with primary ITP
(platelets count <30 G/L) who require first-line standard-of-care corticosteroids.
After completion of the screening period, the participants will enter the randomized
treatment period (ianalumab/placebo with standard of care corticosteroids).
After the treatment period, all participants will enter the follow-up period to be
monitored for efficacy and safety or safety only depending on how they respond to the
study treatment.
Novartis Pharmaceuticals
225Patients around the world
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Signed informed consent prior to participation in the study.Male or female participants aged 18 years and older on the day of signing informed consentPrimary ITP diagnosed within 3 months before initiating first-line ITP therapy (corticosteroids, IVIG)Platelet count below 30 G/L before starting any first-line ITP therapy (corticosteroids, IVIG)Response (platelet count >=50 G/L) to corticosteroids (+/- IVIG) at any time prior to randomization. Note: Platelet count measured within 7 days of platelet transfusion will not be considered as response.
- Evans syndrome or any other cytopeniaCurrent life-threatening bleedingPrevious ITP treatment, including splenectomy, except for corticosteroids and/or IVIG initiated as first-line therapy for up to 28 days before randomization and rescue corticosteroids and/or IVIG given prior to confirmed diagnosis of primary ITP .Prior use of B-cell depleting therapy (e.g., rituximab).Absolute neutrophil count below 1.0 G/L at randomizationParticipants with concurrent coagulation disorders and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid
StudyVAYHIT1
SponsorNovartis Pharmaceuticals
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05653349
